Condition 1: Diabetic foot ulcer caused by type 1 diabetes. Condition 2: Diabetic foot ulcer caused by type 2 diabetes. Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene
Conditions
Interventions
Intervention 1: Intervention group: Both groups (intervention and control) receive routine treatment including debridement, infection control and treatment (if the wound becomes infected), hospitaliza
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with type 1 or 2 Diabetes Age 30 years or older Grade 1 and 2 diabetic ulcers according to Wagner classification system Adherence to routine diabetes treatments Ankle Brachial Index (ABI) greater than 0.7
Exclusion criteria
Exclusion criteria: Pregnancy or Breastfeeding Presence of infection in the wound before admission Presence of neoplasia Use of immunosuppressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area and dimensions. Timepoint: Weekly for 8 weeks. Method of measurement: Photography of ulcers and Computer software.;Presence or absence of infection in the wound. Timepoint: Weekly for 8 weeks. Method of measurement: Wound examination and Visual observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of side effects. Timepoint: Evaluation will be weekly from the first week to the eighth week. Method of measurement: Asking the patient and Examining the wound by the visitor (symptoms such as burning, itching, redness, etc. while using the gel).;Tolerability. Timepoint: Evaluation will be weekly from the first week to the eighth week. Method of measurement: Ask the patient if there is any discomfort while taking the drug or If there is any factor that makes the patient reluctant to continue treatment and the cause is related to the gel used.;Pain assessment. Timepoint: Before the intervention and the end of the eighth week. Method of measurement: The patient scores from one to ten, depending on the amount of pain he feels.(Visual Analogue Scale).;Quality of life score. Timepoint: Before the intervention and the end of the eighth week. Method of measurement: Questionnaire for quality of life of patients with diabetic foot ulcers.(Designed by Johnson in the UK, 1995). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Mahdi Ahmadian-Attari
Karaj University of Medical Sciences
Outcome results
None listed